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ICH Q9 (R1): The Next Frontier

ISPE

ICH Q9 (R1): The Next Frontier Trudy Patterson Fri, 07/21/2023 - 11:53 iSpeak Blog iSpeak ICH Q9 (R1): The Next Frontier Christopher John Potter, PhD 21 July 2023 A one-day seminar titled ICH Q9(R1): The Next Frontier was hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (TU Dublin) on 1 June 2023.

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Staying abreast of regulations with NGS?based viral safety for faster, safer and more ethical lot release of our vaccines

European Pharmaceutical Review

A typical example is the classical biosafety animal testing driven by a collection of guidance documents that often were not revised for decades (eg, ICHQ 5A). However, the biosafety testing strategies rely on outdated technologies that have remained unchanged for decades. In vivo and in vitro tests were very powerful when first implemented.

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How Can I Earn CME Credits?

Board Vitals - Pharmacist

Events sponsored by an accredited CME provider include national, regional, or local conferences, workshops, seminars, journal clubs, simulation labs, and live webinars. This method is truly a type of self-directed learning in which you document a clinical question, the sources consulted, and the application to your practice. .

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Time to change the channel? The future for customer engagement models

pharmaphorum

Documenting the change in pharma’s engagement of HCPs is one thing – predicting where channel mix goes in the future, the most important question, is quite another. Preference shifts for the other two groupings, meetings events and seminars (in person or remote) and published medical content, see some, but much more minor, shifts.

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International Collaboration and Reliance: Regulatory Panel Discussion at the 2022 ISPE Singapore Conference

ISPE

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry.

FDA 97
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Regulatory Panel Discussion on International Collaboration and Reliance

ISPE

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry.

FDA 52